BVA-200 vs BVA-100 Validation Study

Completed

Conditions studied: Heart Failure, High Blood Pressure, High Cholesterol, Anemia, Diabetes, Thyroid Diseases, Kidney Diseases, Clotting Disorder, Trauma, Other Disease

In brief

The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device. Data from this study may be pooled with data from studies with similar design conducted at other sites, for the purposes of an FDA medical device submission.

Key facts

Study ID

NCT06227819

Run by

Daxor Corporation

People needed

62

Starts

2023-05-23

Expected to finish

2023-11-30

Last updated by the study team

2024-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age: Over18 years;
• Able and willing to provide informed written consent.
• Subjects will be enrolled who have been prescribed a blood volume procedure using the BVA-100, as a result either of their ordinary diagnostic care or of their participation in another study that uses blood volume measurement. Subjects will be adults under treatment for conditions normally associated with the need for volume assessment, such as Heart Failure, or scheduled to receive BVA-100 measurement as part of another study.

You may not qualify if…

• Pregnant women or nursing mothers.
• Women of childbearing potential not using adequate birth control methods.
• Known hypersensitivity to iodine or eggs.
• Other clinical basis for precluding the use of radioactive materials.
• Has previously been enrolled in, and completed, the study.

Where it is running

• Daxor Corporation — Oak Ridge, Tennessee, United States

Full record on ClinicalTrials.gov

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